Tissue extraction devices and methods

ABSTRACT

A tissue cutting device has an outer sleeve with a distal window and an inner cutting sleeve which moves past the window to cut tissue. The inner cutting sleeve has a lumen which may have a larger proximal diameter than distal diameter. A perimeter of the window may comprise a dielectric material. A distal edge of the inner sleeve may be displaced inwardly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/982,593, filed Dec. 29, 2015, now U.S. Pat. No. 9,827,037, which is acontinuation of U.S. application Ser. No. 13/442,686, filed Apr. 9,2012, now U.S. Pat. No. 9,254,142, which claims the benefit of U.S.Provisional Application No. 61/474,164, filed Apr. 11, 2011, and U.S.Provisional Application No. 61/501,438, filed Jun. 27, 2011. Thisapplication is also related to but does not claim priority from U.S.application Ser. No. 13/277,913, filed Oct. 20, 2011, now U.S. Pat. No.8,512,326, and U.S. application Ser. No. 13/287,315, filed Nov. 2, 2011now U.S. Pat. No. 8,323,280. The entire contents of each of theseapplications is incorporated herein in its entirety by reference.

TECHNICAL FIELD

The present invention relates systems and methods for the cutting andextraction of uterine fibroid tissue, polyps and other abnormal uterinetissue.

BACKGROUND

Uterine fibroids are non-cancerous tumors that develop in the wall ofuterus. Such fibroids occur in a large percentage of the femalepopulation, with some studies indicating up to 40 percent of all womenhave fibroids. Uterine fibroids can grow over time to be severalcentimeters in diameter and symptoms can include menorrhagia,reproductive dysfunction, pelvic pressure and pain.

One current treatment of fibroids is hysteroscopic resection ormyomectomy which involves transcervical access to the uterus with ahysteroscope together with insertion of a cutting instrument through aworking channel in the hysteroscope. The cutting instrument may be amechanical tissue cutter or an electrosurgical resection device such asa cutting loop. Mechanical cutting devices are disclosed in U.S. Pat.Nos. 7,226,459; 6,032,673 and 5,730,752 and U.S. Published Patent Appl.2009/0270898. An electrosurgical cutting device is disclosed in U.S.Pat. No. 5,906,615.

In a myomectomy or hysteroscopic resection, the initial step of theprocedure includes distention of the uterine cavity to create a workingspace for assisting viewing through the hysteroscope. In a relaxedstate, the uterine cavity collapses with the uterine walls in contactwith one another. A fluid management system is used to distend theuterus to provide a working space wherein a fluid is administeredthrough a passageway in the hysteroscope under sufficient pressure toexpand or distend the uterine cavity. The fluids used to distend theuterus are typically liquid aqueous solutions such as a saline solutionor a sugar-based aqueous solution.

In some RF electrosurgical resection procedures, the distending fluid isa non-conductive aqueous solution to limit RF current conduction.

One particular concern is the fact that fluid management systemstypically administer the fluid under a pressure of up to 100 mm Hg ormore which results in a significant risk that the distending fluid maybe taken up by a cut blood vessel exposed in the uterine cavity. Suchunwanted fluid uptake is known as intravasation, which can lead toserious complications and even death. For this reason, fluid managementsystems have been developed to monitor the patient's fluid uptake on acontinuous basis during a procedure, typically using complicated systemsthat capture, collect and weigh distending fluids that flow through theuterine cavity.

While hysteroscopic resection can be effective in removing uterinefibroids, many commercially available instrument are too large indiameter and thus require anesthesia in an operating room environment.Conventional resectoscopes require cervical dilation to about 9 mm. Whatis needed is a system that can effectively cut and remove fibroid tissuethrough a small diameter hysteroscope.

BRIEF SUMMARY

The present invention comprises a tissue cutting device including anelongated structure where the elongated structure comprises an outersleeve and an inner cutting sleeve. The elongated structure willtypically be attached at a proximal end to a hub, handle, or othercomponent to allow manipulation of the device. The elongated structurewill be in the form of a shaft suitable for introduction to a bodycavity, for example for transcervical introduction to a uterus. Acutting window will be formed through a wall at a distal end of thesleeve, and the inner sleeve will be configured to move between aproximal position and a distal position relative to the cutting window.In particular, the inner cutting sleeve will typically have a distalcutting edge, such as a sharpened edge, an electrosurgical edge, or thelike, which allows the inner sleeve to be advanced past the cuttingwindow in the outer sleeve in order to cut, sever, or otherwise removetissue which intrudes inwardly through the window. The inner sleeve willhave an interior lumen extending at least partly therethrough to allowtissue to be extracted after it has been severed.

In a first aspect of the present invention, the tissue-extracting lumenof the inner cutting sleeve has a distal luminal portion having a firstdiameter and a proximal luminal portion having a second diameter. Thefirst distal diameter will usually be less than the second proximaldiameter so that the cross-sectional area of the distal portion is lessthan that of the proximal portion of the lumen.

Usually, the distal lumen portion will have a length which is only asmall fraction of the length of the total tissue-extracting lumen. Thetotal length of the tissue-extracting lumen for a device configured fortranscervical introduction into a uterus, including both the distal andproximal luminal portions, will typically be in the range from 450 mm to550 mm, with the distal luminal portion with usually extending at least1 mm from a distal end of the inner cutting sleeve, often extending atleast 2 mm from the distal end of the inner cutting sleeve. The distalluminal portion will usually have a maximum length no greater than 15mm, more usually being no greater than 10 mm. Thus, the distal lumenportion will usually have a length and range from 1 mm to 15 mm, oftenbeing in the range from 2 mm to 10 mm.

The inner cutting sleeve and the outer sleeve will typically both becylindrical at at least their distal ends in order to permit relativerotation and optionally rotational oscillation. In other instances,however, the sleeves or some portion thereof could have non-circularcross-sectional areas where the diameter ranges set forth above will beequivalent to an average width of the lumen in any point. Thecross-sectional area of the distal luminal portion will typically beless than 95% of the cross-sectional area of the proximal luminalportion, more usually being less than 90% of the cross-sectional area ofthe proximal luminal portion. Usually, the cross-sectional area of thedistal luminal portion will be less than 95% of the cross-sectional areaof the proximal luminal portion, more usually being less than 90% of thecross-sectional area of the proximal luminal portion. Thecross-sectional area of the distal luminal portion relative to theproximal luminal portion will typically be in the range from 80% to 95%,more usually in the range from 90% to 95%.

In another aspect of the present invention, a perimeter of the distal orcutting window in the outer sleeve will comprise a dielectric material,such as a ceramic material, a polymeric material, or the like. Thedielectric material about the window perimeter functions to providespacing between the opposing polarity electrode surfaces of the innercutting sleeve and the outer sleeve.

In a further aspect of the present invention, the inner sleeve of thetissue cutting device has a distal tissue-contacting edge that isdisplaced radially inwardly from an outer diameter of said inner sleeve,where the displaced edge typically comprises an electrode. In suchcases, a dielectric layer will usually be formed on or over an interiorof the outer sleeve.

In a still further aspect of the present invention, a ratio of thediameter of at least a proximal portion of the tissue-extraction lumento the outer diameter of the outer sleeve will be at least 0.65 to 1,usually being at least 0.70 to 1.

In yet another aspect of the present invention, the tissue cuttingsystem will further comprise a hysteroscope, and a ratio of the diameterof the tissue-extraction lumen to an outer diameter of the hysteroscopewill be at least 0.35 to 1, preferably being at least 0.4 to 1.

In still another aspect of the present invention, a tissue cutting probecomprises first and second concentric sleeves having a common axis,where the sleeves are configured for relative axial movement between awindow-open position for receiving tissue therethrough and a range ofwindow-closing positions in which the second sleeve is adapted to cuttissue which is received through the window in the first sleeve. Theprobe further comprises a motor to provide relative movement of thesleeves, including rotation, rotational oscillation, and/or axialtranslation) to effect cutting, and each of the sleeves comprises atissue-contacting edge, where the contacting edge of one sleevescomprises an electrode and the contacting edge of the other sleevecomprises a dielectric. The dielectric maybe on at least one interfacingsurface of the first and second sleeves, and often will be on thesurfaces of both the first and second sleeves. Optionally, the first andsecond sleeves comprise opposing polarity electrodes which maybe coupledto a radiofrequency source.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a plan view of an assembly including a hysteroscope and atissue-cutting device corresponding to the invention that is insertedthrough the working channel of the hysteroscope.

FIG. 2 is a schematic perspective view of a fluid management system usedfor distending the uterus and for assisting in electrosurgical tissuecutting and extraction.

FIG. 3 is a cross-sectional view of the shaft of the hysteroscope ofFIG. 1 showing various channels therein.

FIG. 4 is a schematic view of the working end of the electrosurgicaltissue-cutting device of FIG. 1 showing an outer sleeve with areciprocating inner cutting sleeve in a partially advanced position.

FIG. 5 is a schematic perspective view of the working end of the innersleeve of FIG. 4 showing its electrode edge.

FIG. 6A is a schematic cut-away view of a portion of outer sleeve, innerRF cutting sleeve and a tissue-receiving window of the outer sleeve.

FIG. 6B is a schematic view of a distal end portion another embodimentof inner RF cutting sleeve.

FIG. 7A is a cross sectional view of the inner RF cutting sleeve of FIG.6B taken along line 7A-7A of FIG. 6B.

FIG. 7B is another cross sectional view of the inner RF cutting sleeveof FIG. 6B taken along line 7B-7B of FIG. 6B.

FIG. 8 is a schematic view of a distal end portion of another embodimentof inner RF cutting sleeve.

FIG. 9A is a cross sectional view of the RF cutting sleeve of FIG. 8taken along line 9A-9A of FIG. 8 .

FIG. 9B is a cross sectional view of the RF cutting sleeve of FIG. 8taken along line 9B-9B of FIG. 8 .

FIG. 10A is an enlarged sectional view of a working end with an RFcutting sleeve in a partially advanced position illustrating fluidvolumes that comprise a fluidic pumping mechanism corresponding to theinvention for displacement of captured tissue.

FIG. 10B is another enlarged sectional view similar to FIG. 10A with theRF cutting sleeve in a further advanced position showing how a capturedfluid volumes applies fluidic or hydraulic pressure to captured tissue.

FIG. 11A is a longitudinal sectional view a working end illustrating anelectrode edge cutting tissue.

FIG. 11B is a longitudinal sectional view similar to FIG. 11Aillustrating the pumping function of the working end.

FIG. 12A is a cross-section of a sleeve assembly showing a fluid inflowlumen.

FIG. 12B is a cross-section of a sleeve assembly showing an alternativefluid inflow lumen.

FIG. 12C is a cross-section of a sleeve assembly showing an alternativefluid inflow lumen.

FIG. 13 is a sectional view of a variation of cutting sleeve with aninwardly displaced electrode edge.

FIG. 14 is a perspective view of another variation with an exteriorsleeve with a distal dielectric body portion.

DETAILED DESCRIPTION

FIG. 1 illustrates an assembly that comprises an endoscope 50 used forhysteroscopy together with a tissue-extraction device 100 extendingthrough a working channel 102 of the endoscope. The endoscope orhysteroscope 50 has a handle 104 coupled to an elongated shaft 105having a diameter of 5 mm to 7 mm. The working channel 102 therein maybe round, D-shaped or any other suitable shape. The endoscope shaft 105is further configured with an optics channel 106 and one or more fluidinflow/outflow channels 108 a, 108 b (FIG. 3 ) that communicate withvalve-connectors 110 a, 110 b configured for coupling to a fluid inflowsource 120 thereto, or optionally a negative pressure source 125 (FIGS.1-2 ). The fluid inflow source 120 is a component of a fluid managementsystem 126 as is known in the art (FIG. 2 ) which comprises a fluidcontainer 128 and pump mechanism 130 which pumps fluid through thehysteroscope 50 into the uterine cavity. As can be seen in FIG. 2 , thefluid management system 126 further includes the negative pressuresource 125 (which can comprise an operating room wall suction source)coupled to the tissue-cutting device 100. The handle 104 of theendoscope includes the angled extension portion 132 with optics to whicha videoscopic camera 135 can be operatively coupled. A light source 136also is coupled to light coupling 138 on the handle of the hysteroscope50. The working channel 102 of the hysteroscope is configured forinsertion and manipulation of the tissue-cutting and extracting device100, for example to treat and remove fibroid tissue. In one embodiment,the hysteroscope shaft 105 has an axial length of 21 cm, and cancomprise a 0° scope, or 15° to 30° scope.

Still referring to FIG. 1 , the tissue-cutting device 100 has a highlyelongated shaft assembly 140 configured to extend through the workingchannel 102 in the hysteroscope. A handle 142 of the tissue-cuttingdevice 100 is adapted for manipulating the electrosurgical working end145 of the device. In use, the handle 142 can be manipulated bothrotationally and axially, for example, to orient the working end 145 tocut targeted fibroid tissue. The tissue-cutting device 100 hassubsystems coupled to its handle 142 to enable electrosurgical cuttingof targeted tissue. A radio frequency generator or RF source 150 andcontroller 155 are coupled to at least one RF electrode carried by theworking end 145 as will be described in detail below. In one embodimentshown in FIG. 1 , an electrical cable 156 and negative pressure source125 are operatively coupled to a connector 158 in handle 142. Theelectrical cable couples the RF source 150 to the electrosurgicalworking end 145. The negative pressure source 125 communicates with atissue-extraction channel 160 in the shaft assembly 140 of the tissueextraction device 100 (FIG. 4 ).

FIG. 1 further illustrates a seal housing 162 that carries a flexibleseal 164 carried by the hysteroscope handle 104 for sealing the shaft140 of the tissue-cutting device 100 in the working channel 102 toprevent distending fluid from escaping from a uterine cavity.

In one embodiment as shown in FIG. 1 , the handle 142 of tissue-cuttingdevice 100 includes a motor drive 165 for reciprocating or otherwisemoving a cutting component of the electrosurgical working end 145 aswill be described below. The handle 142 optionally includes one or moreactuator buttons 166 for actuating the device. In another embodiment, afootswitch can be used to operate the device. In one embodiment, thesystem includes a switch or control mechanism to provide a plurality ofreciprocation speeds, for example 1 Hz, 2 Hz, 3 Hz, 4 Hz and up to 8 Hz.Further, the system can include a mechanism for moving and locking thereciprocating cutting sleeve in a non-extended position and in anextended position. Further, the system can include a mechanism foractuating a single reciprocating stroke.

Referring to FIGS. 1 and 4 , an electrosurgical tissue-cutting devicehas an elongate shaft assembly 140 extending about longitudinal axis 168comprising an exterior or first outer sleeve 170 with passageway orlumen 172 therein that accommodates a second or inner sleeve 175 thatcan reciprocate (and optionally rotate or oscillate) in lumen 172 to cuttissue as is known in that art of such tubular cutters. In oneembodiment, the tissue-receiving window 176 in the outer sleeve 170 hasan axial length ranging between 10 mm and 30 mm and extends in a radialangle about outer sleeve 170 from about 45° to 210° relative to axis 168of the sleeve. In one embodiment, the window extends in a radial angleof to 180°—that is, the window cut is one-half of the tube. The outerand inner sleeves 170 and 175 can comprise a thin-wall stainless steelmaterial and function as opposing polarity electrodes as will bedescribed in detail below. FIGS. 6A-8 illustrate insulative ordielectric layers carried by the outer and inner sleeves 170 and 175 tolimit, control and/or prevent unwanted electrical current flows betweencertain portions of the sleeve. In one embodiment, a stainless steelouter sleeve 170 has an O.D. of 0.143″ with an I.D. of 0.133″ and withan inner insulative layer (described below) the sleeve has a nominalI.D. of 0.125″. In this embodiment, the stainless steel inner sleeve 175has an O.D. of 0.112″ with an I.D. of 0.106″. The inner sleeve 175 withan outer insulative layer 202 has a nominal O.D. of about 0.120 toreciprocate in lumen 172. In other embodiments, outer and or innersleeves can be fabricated of metal, plastic, ceramic of a combinationthereof. The cross-section of the sleeves can be round, oval or anyother suitable shape.

In one embodiment, the outer sleeve is 17-7 PH stainless steel has anO.D. of 0.140 to 0.143″ with a wall thickness of 0.005″ to 0.007″ andthe inner sleeve also is 17-7. It can be understood that having thelargest possible diameter extraction lumen 160 (FIG. 5 ) isadvantageous, but limited by the O.D. of the shaft assembly which inturn is limited by the desired cross section of the hysteroscope 50. Tominimize dilation of the patient's cervix, the maximum scope diametershould be about 6.5 mm (0.256″) which generally may allow for a maximumworking channel of about 0.150″. It one aspect of the invention, thethin wall tubing and insulation layers have been developed to provide anoptimized tissue extraction lumen diameter (given the above scopedimensions and limitations above) that is greater than 0.090″ or greaterthan 0.100″—all accommodated in hysteroscope having a O.D. of 6.5 mm.

Thus, in general, a tissue cutting device corresponding to the inventioncomprises an elongated assembly comprising concentric outer and innersleeves extending along an axis, a tissue-receiving window in the outersleeve and a reciprocating inner sleeve having a extraction lumen 160therein (FIG. 5 ), and wherein the ratio of the diameter of theextraction lumen 160 to the outer diameter of the outer sleeve is atleast 0.65:1 or at least 0.70:1.

In another aspect, the tissue cutting device and hysteroscope togethercorresponding to the invention comprises an assembly or combinationwherein the ratio of the diameter of the extraction lumen 160 to theouter diameter of the hysteroscope to at least 0.35:1 or at least0.40:1.

As can be seen in FIG. 4 , the distal end 177 of inner sleeve 175comprises a first polarity electrode with distal cutting electrode edge180 about which plasma can be generated. The electrode edge 180 also canbe described as an active electrode during tissue cutting since theelectrode edge 180 then has a substantially smaller surface area thanthe opposing polarity or return electrode. In one embodiment in FIG. 4 ,the exposed surfaces of outer sleeve 170 comprises the second polarityelectrode 185, which thus can be described as the return electrode sinceduring use such an electrode surface has a substantially larger surfacearea compared to the functionally exposed surface area of the activeelectrode edge 180.

In one aspect of the invention, the inner sleeve or cutting sleeve 175has an interior tissue extraction lumen 160 with first and secondinterior diameters that are adapted to electrosurgically cut tissuevolumes rapidly—and thereafter consistently extract the cut tissuestrips through the highly elongated lumen 160 without clogging. Nowreferring to FIGS. 5 and 6A, it can be seen that the inner sleeve 175has a first diameter portion 190A that extends from the handle 142 (FIG.1 ) to a distal region 192 of the sleeve 175 wherein the tissueextraction lumen transitions to a smaller second diameter lumen 190Bwith a reduced diameter indicated at B which is defined by the electrodesleeve element 195 that provides cutting electrode edge 180. The axiallength C of the reduced cross-section lumen 190B can range from about 1mm to 15 mm. In one embodiment, the first diameter A is 0.106″ and thesecond reduced diameter B is 0.095″ and has an axial length of 2 mm. Inone embodiment, the cross-sectional area of the distal lumen portion isless than 95% of cross-sectional area of the proximal lumen portion, orless than 90% of the cross-sectional area of the proximal lumen portion.As shown in FIG. 5 , the inner sleeve 175 can be an electricallyconductive stainless steel and the reduced diameter electrode portionalso can comprise a stainless steel electrode sleeve element 195 that iswelded in place by weld 196 (FIG. 6A). In another alternativeembodiment, the electrode and reduced diameter electrode sleeve element195 comprises a tungsten tube that can be press fit into the distal end198 of inner sleeve 175. FIGS. 5 and 6A further illustrates theinterfacing insulation layers 202 and 204 carried by the first andsecond sleeves 170, 175, respectively. In FIG. 6A, the outer sleeve 170is lined with a thin-wall insulative material 200, such as PFA, oranother material described below. Similarly, the inner sleeve 175 has anexterior insulative layer 202. These coating materials can be lubriciousas well as electrically insulative to reduce friction duringreciprocation of the inner sleeve 175.

The insulative layers 200 and 202 described above can comprise alubricious, hydrophobic or hydrophilic polymeric material. For example,the material can comprise a bio-compatible material such as PFA,TEFLON®, polytetrafluroethylene (PTFE), FEP (Fluorinatedethylenepropylene), polyethylene, polyamide, ECTFE(Ethylenechlorotrifluoro-ethylene), ETFE, PVDF, polyvinyl chloride orsilicone.

Now turning to FIG. 6B, another variation of inner sleeve 175 isillustrated in a schematic view together with a tissue volume beingresected with the plasma electrode edge 180. In this embodiment, as inother embodiments in this disclosure, the RF source operates at selectedoperational parameters to create a plasma around the electrode edge 180of electrode sleeve 195 as is known in the art. Thus, the plasmagenerated at electrode edge 180 can cut and ablate a path P in thetissue 220, and is suited for cutting fibroid tissue and other abnormaluterine tissue. In FIG. 6B, the distal portion of the cutting sleeve 175includes a ceramic collar 222 which is adjacent the distal edge 180 ofthe electrode sleeve 195. The ceramic 222 collar functions to confineplasma formation about the distal electrode edge 180 and functionsfurther to prevent plasma from contacting and damaging the polymerinsulative layer 202 on the cutting sleeve 175 during operation. In oneaspect of the invention, the path P cut in the tissue 220 with theplasma at electrode edge 180 provides a path P having an ablated widthindicated at W, wherein such path width W is substantially wide due totissue vaporization. This removal and vaporization of tissue in path Pis substantially different than the effect of cutting similar tissuewith a sharp blade edge, as in various prior art devices. A sharp bladeedge can divide tissue (without cauterization) but applies mechanicalforce to the tissue and may prevent a large cross section slug of tissuefrom being cut. In contrast, the plasma at the electrode edge 180 canvaporize a path P in tissue without applying any substantial force onthe tissue to thus cut larger cross-sections of strips of tissue.Further, the plasma cutting effect reduces the cross section of tissuestrip 225 received in the tissue-extraction lumen 190B. FIG. 6B depictsa tissue strip to 225 entering lumen 190B which has such a smallercross-section than the lumen due to the vaporization of tissue. Further,the cross section of tissue 225 as it enters the larger cross-sectionlumen 190A results in even greater free space 196 around the tissuestrip 225. Thus, the resection of tissue with the plasma electrode edge180, together with the lumen transition from the smaller cross-section(190B) to the larger cross-section (190A) of the tissue-extraction lumen160 can significantly reduce or eliminate the potential for successiveresected tissue strips 225 to clog the lumen. Prior art resectiondevices with such small diameter tissue-extraction lumen typically haveproblems with tissue clogging.

In another aspect of the invention, the negative pressure source 225coupled to the proximal end of tissue-extraction lumen 160 (see FIGS. 1and 4A) also assists in aspirating and moving tissue strips 225 in theproximal direction to a collection reservoir (not shown) outside thehandle 142 of the device.

FIGS. 7A-7B illustrate the change in lumen diameter of cutting sleeve175 of FIG. 6B. FIG. 8 illustrates the distal end of a variation ofcutting sleeve 175′ which is configured with an electrode cuttingelement 195′ that is partially tubular in contrast to the previouslydescribed tubular electrode element 195 (FIGS. 5 and 6A). FIGS. 9A-9Bagain illustrate the change in cross-section of the tissue-extractionlumen between reduced cross-section region 190B′ and the increasedcross-section region 190A′ of the cutting sleeve 175′ of FIG. 8 . Thus,the functionality remains the same whether the cutting electrode element195′ is tubular or partly tubular. In FIG. 8A, the ceramic collar 222′is shown, in one variation, as extending only partially around sleeve175 to cooperate with the radial angle of cutting electrode element195′. Further, the variation of FIG. 8 illustrates that the ceramiccollar 222′ has a larger outside diameter than insulative layer 202.Thus, friction may be reduced since the short axial length of theceramic collar 222′ interfaces and slides against the interfacinginsulative layer 200 about the inner surface of lumen 172 of outersleeve 170.

In general, one aspect of the invention comprises a tissue cutting andextracting device (FIGS. 4A-4B) that includes first and secondconcentric sleeves having an axis and wherein the second (inner) sleeve175 has an axially-extending tissue-extraction lumen therein, andwherein the second sleeve 175 is moveable between axially non-extendedand extended positions relative to a tissue-receiving window 176 infirst sleeve 170 to resect tissue, and wherein the tissue extractionlumen 160 has first and second cross-sections. The second sleeve 175 hasa distal end configured as a plasma electrode edge 180 to resect tissuedisposed in tissue-receiving window 176 of the first sleeve 170.Further, the distal end of the second sleeve, and more particularly, theelectrode edge 180 is configured for plasma ablation of a substantiallywide path in the tissue. In general, the tissue-extraction device isconfigured with a tissue extraction lumen 160 having a distal endportion with a reduced cross-section that is smaller than across-section of medial and proximal portions of the lumen 160.

In one aspect of the invention, referring to FIGS. 7A-7B and 9A-9B, thetissue-extraction lumen 160 has a reduced cross-sectional area in lumenregion 190A proximate the plasma cutting tip or electrode edge 180wherein said reduced cross section is less that 95%, 90%, 85% or 80%than the cross sectional area of medial and proximal portions 190B ofthe tissue-extraction lumen, and wherein the axial length of thetissue-extraction lumen is from 450 mm to 550 mm for access to a uterinecavity. In one embodiment of tissue-cutting device 100 for hysteroscopicfibroid cutting and extraction (FIG. 1 ), the shaft assembly 140 of thetissue-cutting device is 35 cm in length. Devices used for otherprocedures can have tissue-extraction lumen that are at least 10 cm, 20cm, 30 cm or 40 cm in length.

Now referring to FIG. 4 , FIGS. 10A-10B and FIGS. 11A-11B, one aspect ofthe invention comprises a “tissue displacement” or pump means that isconfigured to displace and move tissue strips 225 (see FIGS. 11A-11B) inthe proximal direction in lumen 160 of cutting sleeve 175 to thus ensurethat tissue does not clog the lumen of the inner sleeve 175. As can beseen in FIGS. 4 and 10A-10B, the pump means as a tissue displacementmechanism comprises a volume of captured fluid indicated at 400 (phantomoutline in FIG. 4) that is captured in a terminal chamber 405 of theassembly that is defined by the lumen 172 of outer sleeve and the distaltip or body 232 that is fixedly attached to outer sleeve 170.

As shown in FIG. 10A, the proximal end 406 of the terminal chamber 405is defined by a plane transverse to axis 168 at the distal edge of thewindow 176. In one embodiment, the axial length L of the terminalchamber 405 is at least 3 mm, 4 mm of 5 mm. In general, a tissue cuttingdevice comprises an elongated assembly comprising concentric outer andinner sleeves extending along an axis, a tissue-receiving window in theouter sleeve open to an interior lumen that extends to a terminalchamber that is distal to the window, wherein the terminal chamberdefines a fluid volume of at least 0.01 mL, at least 0.02 mL or at least0.04 mL. In one embodiment, the terminal chamber is cylindrical and hasa length to diameter ratio of at least 1:1, or at least 1.5:1.

In one embodiment depicted in FIGS. 4 and 10A, the fluid in chamber 405functions as a fluid piston to pump fluid or tissue in cylindricalchamber 410 defined by the electrode sleeve 195 and the adjoiningextraction lumen 160. Of particular interest, the captured fluid 400 canfunction as a pump and can push a captured tissue strip 225 in theproximal direction from the small cross-section lumen 190B in electrodesleeve 155 as the cutting or inner sleeve 175 moves to its fullyadvanced or extended position (see. FIG. 10B). For this reason, theabove described length L of the terminal chamber 405 is at least asgreat as the axial length E of the small cross-section lumen 190B in thecutting sleeve 175. Further, as depicted in FIGS. 10A-10B and 11A-11B,the pumping stroke Y of the cutting sleeve 175 extends at least about 3mm, 4 mm or 5 mm distally beyond the distal edge of the window 290. Inanother aspect, the stroke Y of the cutting sleeve 175 is at least 5% or10% of the total stroke of the cutting sleeve (stroke X+stroke Y in FIG.11A).

In general, a method of cutting tissue corresponding to the inventioncomprises cutting tissue with a reciprocating cutting sleeve having anextending stroke and a retracting stroke within an outer sleeve, whereinthe extending stroke cuts and captures tissue received by atissue-receiving window in the outer sleeve; and moving the capturedtissue proximally in the cutting sleeve with fluidic pressure. Thefluidic pressure is provided by the captured fluid volume 400 in chamber405 in reaction to the relative motion of the fluid volume 400 and thecutting sleeve 175 within which a tissue strip 225 is disposed. As canbe understood from FIGS. 10B and 11B, the fluidic pressure issubstantially applied when the extending stroke of the sleeve 175 isdistal of the window. In one method, the fluidic pressure is applied bya volume of distending fluid from the fluid-immersed working space thatis captured in the closed-end terminal chamber 405 of outer sleeve 170.The method includes cutting tissue with an RF plasma at a distalelectrode edge 180 of the electrode sleeve 195. In another method, thefluid could be entirely or a partially supplied by a pressurized fluidinflow from a remote source through a flow passageway 415 in outersleeve 170 as depicted in FIG. 12A, a flow passageway 416 in innersleeve 175 as depicted in FIG. 12B, or a flow passageway 420 formedintermediate the walls of the outer and inner sleeves 170, 175 asdepicted in FIG. 12C.

In one embodiment depicted in FIGS. 4 and 10A, the fluid in chamber 405functions as a fluid piston to pump fluid or tissue in cylindricalchamber 410 defined by the electrode sleeve 195 and the adjoiningextraction lumen 160. Of particular interest, the captured fluid 400 canfunction as a pump and can push a captured tissue strip 225 in theproximal direction from the small cross-section lumen 190B in electrodesleeve 155 as the cutting or inner sleeve 175 moves to its fullyadvanced or extended position (see. FIG. 10B). For this reason, theabove described length L of the terminal chamber 405 is at least asgreat as the axial length E of the small cross-section lumen 190B in thecutting sleeve 170. Further, as depicted in FIGS. 10A-10B and 11A-11B,the stroke Y of the cutting sleeve 175 extends at least about 3 mm, 4 mmor 5 mm distally beyond the distal edge of the window 290. In anotheraspect, the stroke Y of the cutting sleeve 175 is at least 5% or 10% ofthe total stroke of the cutting sleeve (stroke X+stroke Y in FIG. 11A).

In general, a method of cutting tissue corresponding to the inventioncomprising cutting tissue with a reciprocating cutting sleeve having anextending stroke and a retracting stroke within an outer sleeve, whereinthe extending stroke cuts and captures tissue received by atissue-receiving window in the outer sleeve, and pushing the capturedtissue in the proximal direction in the cutting sleeve with fluidicpressure provided by the captured fluid volume 400 in chamber 405.Further, the fluidic pressure and pump or displacement mechanism isconfigured to push the captured tissue at least in part from a firstsmaller cross-section lumen 190B to a second larger cross-section lumen190A in the cutting sleeve 175. Thereafter, the negative pressure sourcecan more effectively extract and aspirate the tissue from the lumen.

In another aspect and method of the invention, tissue is cut andextracted by (i) interfacing a probe working end with targeted tissuewherein the working end comprises an elongated outer sleeve with awindow exposed to a reciprocating inner sleeve, (ii) extending the innersleeve in a first cutting stroke distally across the window therebycutting tissue disposed within the window and (iii) extending the innersleeve in a second pumping stroke distally beyond the window therebycausing fluidic pressure to pump the tissue proximally in a lumen of theinner sleeve. The sequence can be repeated with the first cuttingstroke, the second pumping stroke and the retracting stroke having arate of at least 1 Hz, 2 Hz or 3 Hz. The tissue can be cut with anelectrode edge or a blade edge.

In another variation, the terminal chamber 405 is configured to capturea fluid volume sufficient to fill said inner sleeve lumen 160 over alength of at least 3 mm, 4 mm or 5 mm.

In another variation, the cutting step can include applying RF currentto generate plasma at an electrode edge 180 on inner sleeve 175 andfurther comprising the step of terminating RF current at the end of thefirst cutting stroke. Alternatively, the system and controller 155 canterminate RF current during the second cutting stroke. Alternatively,the controller 155 can terminate RF current during the retractingstroke.

In another variation, the controller can apply RF current to theelectrodes during at least a portion of the retracting stroke to therebycauterize adjacent tissue. The cautery effect can be provided during theretracting stroke at the same operational parameters as used during thefirst cutting stroke, or at different operational RF parameters thanused during the first cutting stroke.

FIGS. 11A-11B illustrate in more detail the functional pump aspects ofthe invention. In FIG. 11A, the reciprocating cutting sleeve 175 isshown in a medial position advancing distally wherein plasma at thecutting electrode edge 180 is cutting a tissue strip 225 that isdisposed within lumen 160 of the cutting sleeve 175. The distendingfluid (saline) 244 from the working space migrates through window 176into terminal chamber 405 to provide the fluid volume that will becaptured upon advancement of the cutting sleeve saline.

In FIG. 11A, it can be seen that the system operates in firstelectrosurgical mode corresponding to the reciprocation and axial rangeof motion of cutting sleeve 175 relative to the tissue-receiving window176. The electrical fields EF of the first mode are indicated in FIG.11A. As described above, the first RF mode can be used over an axiallength of travel of inner cutting sleeve 175 as it crosses thetissue-receiving window 176, or the over both the cutting and pumpingstrokes, and also optionally the retraction stroke.

FIG. 11B illustrates the fluid volume 400 in chamber 405 functioning asa fluid piston and pumping fluid and thus hydraulic or fluidic pressureagain tissue strip 225 and moving the tissue proximally relative to thechamber defined by electrode sleeve 195 and the adjoining extractionlumen 160 (cf. FIG. 10B)

In another aspect of the invention, referring back to FIG. 4 , theworking end comprises first and second converging tissue-contactingedges, 180 and 440, for cutting tissue engaged by or proximate to suchedges. In FIG. 4 , it can be seen that a first edge comprises theelectrode edge 180 described previously. The second first edge 440comprises an edge of the window 176 that comprises a dielectric orinsulative material such as a ceramic of polymeric material. In oneembodiment, the tissue cutting probe comprises first and secondconcentric sleeves having and axis and configured for relative axialmovement between a window-open position for receiving tissue therein anda range of window-closing positions in which the second sleeve cutstissue in a window in the first sleeve, a motor for providing relativemovement of the sleeves, wherein each of said sleeves comprising atissue-contacting edge for contacting tissue, and wherein the contactingedge of one sleeve comprising an electrode and the contacting edge ofthe other sleeve comprising a dielectric.

In one variation, the tissue cutting probe includes an electricallyinsulative layer disposed on at least one interfacing surface of thefirst and second sleeves. In another variation, the tissue cutting probehas an electrically insulative layer disposed the interfacing surfacesof both the first and second sleeves.

In another variation, the interface between the first and second sleevesprovides hydraulic resistance to substantially prevent liquid flowtherethrough. To provide such hydraulic resistance the electricallyinsulative layer of one or both sleeves at the interface comprises ahydrophilic surface. In another variation, an electrically insulativelayer comprises a hydrophobic surface or an ultrahydrophobic surface.

Now referring to FIG. 13 , in another feature of the invention, it hasbeen found that controlled spacing between the plasma-forming electrode180 and the return electrode 185 (FIG. 4 ) is desirable. For thisreason, the electrode-sleeve has a displaced tissue-contacting edge 445that is displaced dimension DD radially inward from an outer diameter ofsaid second or cutting sleeve 175. In general, the tissue cutting probecomprises first and second concentric sleeves having and axis andconfigured for relative axial movement between a window-open positionfor receiving tissue therein and a range of window-closing positions inwhich the second sleeve cuts tissue in a tissue-receiving window in thefirst sleeve, a mechanism for providing relative movement of thesleeves, and wherein the second sleeve has a displaced tissue-contactingedge that is displaced selected dimension radially inward from a outerdiameter of said second sleeve. In one variation, the edge 444 isdisplaced a dimension DD radially inward of at least 0.003″. Theinwardly spaced edge further can be configured with a ceramic collarfixed about the exterior of the sleeve proximate to the displaced edge(FIG. 13 ).

In another aspect of the invention, referring to FIG. 14 , the workingend 145′ can comprise and outer metal sleeve 170 that is coupled to adielectric body 450 of a ceramic or polymeric material that comprises athin-wall structure bonded to sleeve 170 and extends substantiallyaround the perimeter of window 176 and provides the interior terminalfluid chamber described above. In another aspect of the invention, thedielectric material provides further spacing between the first polarityelectrode surface of the inner cutting sleeve (see. FIG. 4 ) and thesecond polarity electrode of the outer sleeve 170 (see FIGS. 4 and 14 ).A lower portion 455 of the metal sleeve can remain in place to addstrength to the structure. In one variation, at least one aperture 460is provided close to an axially-transverse plane at the distal edge ofwindow 176. Such an aperture can provide for rapid flow of distentionfluid into the terminal chamber. Such at least one aperture will beblocked by sleeve 175 during the pumping stroke (see FIG. 11B).

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

What is claimed is:
 1. A tissue extraction system, comprising: ahysteroscope including a handle coupled to an elongate shaft, thehysteroscope having a working channel and one or more fluid channelsextending through the elongate shaft; a resection device including anelongated shaft assembly configured to extend through the workingchannel, the elongated shaft assembly including an outer sleeve having atissue-receiving window through a side wall of the outer sleeve into alumen of the outer sleeve, and an inner sleeve slidably disposed withinthe lumen of the outer sleeve and configured to resect tissue extendingthrough the tissue-receiving window into the lumen of the outer sleeveby sliding the inner sleeve axially relative to the outer sleeve from awindow open configuration to a window closed configuration; and a fluidmanagement system including a pump configured to supply an inflow fluidthrough the hysteroscope, wherein the fluid management system includes anegative pressure source in fluid communication with the inner sleeveand configured to extract resected tissue therethrough; wherein theinner sleeve includes an electrode element disposed at least partiallywithin the inner sleeve and extending distally therefrom.
 2. The tissueextraction system of claim 1, wherein the resection device includes aterminal chamber defined by a distal portion of the lumen of the outersleeve and a distal tip fixedly attached to the outer sleeve.
 3. Thetissue extraction system of claim 2, wherein the resection deviceincludes a flow passageway configured to at least partially supplypressurized fluid to the terminal chamber.
 4. The tissue extractionsystem of claim 3, wherein the flow passageway is formed in the outersleeve.
 5. The tissue extraction system of claim 3, wherein the flowpassageway is formed in the inner sleeve.
 6. The tissue extractionsystem of claim 3, wherein the flow passageway is formed by a spacebetween the inner sleeve and the outer sleeve.
 7. The tissue extractionsystem of claim 1, wherein the inner sleeve is configured to axiallyreciprocate within and relative to the outer sleeve.
 8. The tissueextraction system of claim 7, wherein the resection device includes amotor drive for axially reciprocating the inner sleeve relative to theouter sleeve.
 9. The tissue extraction system of claim 1, furthercomprising an RF energy source electrically coupled to the electrodeelement.
 10. The tissue extraction system of claim 1, wherein a tissueextraction lumen extending within the inner sleeve has proximal anddistal cross-sections that differ from each other.
 11. The tissueextraction system of claim 10, wherein the distal cross-section,adjacent a distal end of the inner sleeve, is smaller than the proximalcross-section.
 12. The tissue extraction system of claim 10, wherein thenegative pressure source is coupled to a proximal end of the tissueextraction lumen.
 13. The tissue extraction system of claim 1, wherein aceramic collar is disposed radially outward of the electrode element.14. The tissue extraction system of claim 13, wherein the ceramic collaris disposed distal of a distal end of the inner sleeve.
 15. The tissueextraction system of claim 13, wherein the electrode element extendsdistal of the ceramic collar.
 16. The tissue extraction system of claim1, wherein the electrode element defines a tissue-resecting edge that isdisplaced radially inward from an outer diameter of the inner sleeve.17. A tissue extraction system, comprising: a hysteroscope including ahandle coupled to an elongate shaft, the hysteroscope having a workingchannel and one or more fluid channels extending through the elongateshaft; a resection device including an elongated shaft assemblyconfigured to extend through the working channel, the elongated shaftassembly including an outer sleeve having a tissue-receiving windowthrough a side wall of the outer sleeve into a lumen of the outersleeve, and an inner sleeve slidably disposed within the lumen of theouter sleeve and configured to axially translate in a distal directionrelative to the outer sleeve from a window open configuration to awindow closed configuration; wherein the resection device includes an RFenergy source coupled to an annular electrode disposed within a distalend of the inner sleeve and extending distally of the distal end of theinner sleeve; wherein axial translation of the inner sleeve relative tothe outer sleeve from the window open configuration to the window closedconfiguration resects tissue extending through the tissue-receivingwindow into the lumen of the outer sleeve; and a fluid management systemincluding a pump configured to supply an inflow fluid through thehysteroscope, wherein the fluid management system includes a negativepressure source in fluid communication with the inner sleeve andconfigured to extract resected tissue therethrough.
 18. The tissueextraction system of claim 17, wherein a distal edge of the annularelectrode is disposed proximal of the tissue-receiving window in thewindow open configuration and the distal edge of the annular electrodeis disposed distal of the tissue-receiving window in the window closedconfiguration.
 19. The tissue extraction system of claim 17, wherein theRF energy source is configured to operate at selected parameters togenerate a plasma around a distal edge of the annular electrode.
 20. Thetissue extraction system of claim 17, wherein an inner diameter of theannular electrode is less than an inner diameter of the inner sleeve.